Michael Keyoung, MD, PhD’s Post

The US FDA Grants aNDA Approval to Loteprednol Etabonate Ophthalmic Suspension #lupin #loteprednoletabonate #allergicconjunctivitis #regulatory #usfda #anda #approval #abbreviatednda #loteprednoletabonateophthalmicsuspension #bausch #lomb #alrexophthalmicsuspension

Compounding pharmacies create personalized medications, including capsules, to meet individual patient needs when commercially available options aren't suitable. #medical #medicine #pharmacies #pharmacy #medications #medication #capsules #patient

🚨 Urgent Alert: Counterfeit Version of Botox Found in Several US States 🚨 The FDA has issued a warning regarding unsafe counterfeit versions of Botox (botulinum toxin) discovered in several states and administered for cosmetic purposes. Adverse events, including hospitalizations, have been reported, with symptoms similar to those of botulinum toxin spreading to other parts of the body. * Verify the authenticity of Botox products before usage. *Purchase prescription drugs only from authorized sources to mitigate risks. *Collaborate with regulatory authorities and manufacturers to ensure patient safety. *Let's remain vigilant and prioritize patient well-being. Read more about the FDA's advisory here: [https://lnkd.in/gBqGCKcZ] #HealthAlert #PatientSafety #CounterfeitMedications #FDAAdvisory #BotoxSafety #PublicHealth #AlertaDeSalud #SeguridadDelPaciente #MedicamentosFalsificados #AdvertenciaDeFDA #SeguridadDeBotox #SaludPública

In a significant milestone for UK-based Futura Medical PLC (AIM:FUM, OTC:FAMDF) and a first for the US, the Food and Drug Administration (FDA) has approved the over-the-counter marketing of the company's innovative topical gel for #erectiledysfunction (ED). #MED3000 can now be sold without prescription, paving the way for the topical ED treatment to become available on the shelves of American pharmacies. Boasting a rapid 10-minute onset of action, the product stands apart from prescription-dependent oral medications such as #Cialis and #Viagra, which typically require at least 30 minutes to take effect. The #Futura gel also avoids some common side effects suffered by 'blue pill' users. More at #Proactive #ProactiveInvestors #AIM #OTC #FUM #FAMDF http://ow.ly/Nfb2104Kc1b

QTc information for product label - new draft FDA guidance Important update on cardiac safety of prescription medications in draft guidance #fda #drugdevelopment #drugapproval #labeling #qtc #cardiac #drugsafety

At the request of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) has convened a consensus committee to review the 510(k) clearance process for medical devices.2 Also known as premarket notification, the process in Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already on the market, in which case the device does not need to go through the premarket approval process. The current 510(k) process, as written in statute and implemented by FDA, is intended to meet two primary goals: (1) to make safe and effective devices available to consumers and (2) to promote innovation in the medical device industry. Concern has been raised, however, that the 510(k) process permits inadequately tested devices to reach the market and thereby places the health of patients at risk. There are also concerns that there is a lack of predictability, consistency, and transparency in the process, potentially inhibiting innovation.

On September 29, 2023, and as widely anticipated, the Food and Drug Administration (FDA) announced the publication of a proposed rule to “clarify” that LDTs are medical devices subject to FDA regulation. See our Alert below for a summary of the proposed policy and fundamental questions that remain to be answered. You can also sign up for Covington Alerts here: https://lnkd.in/gPkCW2hS.

Earlier this week we released an email that was sent by the TGA regarding approved and complaint wording of common injectable treatments utilising Schedule 4 prescription drugs. As expected, this sent the industry into a frenzy with questions of where to go to from here. ⁠ ⁠ Our advice at The Aesthetic Collective is to not make any major changes now. This advice from the TGA included the removal of their webpage on approved wording, but has not provided new suggestions or a 2024 version of the regulations. This new advice is expected to be released in January 2024 with a webinar in February. ⁠ ⁠ We will not be making any major changes to marketing, web content or socials for our clients until new suggested terminology has been provided by the TGA. ⁠ ⁠ Any new advice that comes through will be shared as soon as it is available. While we offer services for the aesthetic industry, we also understand that many clinicians take care of their own socials and we want to share this information to ensure they also have the opportunity to do so compliantly without having to invest in our services. ⁠ ⁠ For anyone who has questions, feel free to jump into our DMs. We are all moving through these new changes from governing bodies together, we will never gatekeep advice or suggestions that can help our industry move forward.